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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

The head of the United Kingdom’s regulatory agency has sketched out some of the ways it may change after Brexit. Dr Ian Hudson stressed the UK wants a collaborative, ongoing relationship with the European Medicines Agency (EMA) but is preparing for the opportunities — and risks — that will arise if it fails to secure its preferred position.

Hudson, the chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA), made the comments to a House of Lords life sciences committee meeting. The MHRA chief said the UK had set out its desired future relationship with EMA in a letter two government ministers sent to the Financial Times in July, although as with many aspects of the UK’s position, the letter is clearer on the desired outcomes than how to achieve them in practice.

The failure of negotiators to reach agreements on three sticking points in the first phase of talks means the UK is yet to discuss the topic formally with the European Union. As such, MHRA and the government are preparing for a scenario in which the UK crashes out of the EU regulatory network. Hudson, in keeping with the government line, focused on the opportunities this would create.

"It depends where we get to in the negotiations as to whether there is an ongoing relationship with the EMA and us operating in the system or not," Hudson said. "In the event of the preferred position of that ongoing relationship not being achieved, there may be opportunities. But we’re very conscious that we don’t want to increase burdens on industry."

The industry set out its position on the trade offs between the flexibility of a fully independent MHRA and stability of ongoing ties to EMA in August. That report came out strongly in favor of sticking close to EMA, arguing that, while it may "be theoretically desirable" to free MHRA to chart its own course, the UK is too small for the benefits to outweigh the harm of jeopardizing the UK’s participation in EU systems and processes.

Hudson’s comment suggests this message has reached MHRA and is shaping its thinking. Even so, the precarious nature of the negotiations and deadline for their completion means MHRA has to assess how to make the best of a hard split from EMA.

"There may be alternatives in terms of accelerating the review process, closer links between [MHRA and NICE], building on the earlier access to medicines scheme, that sort of thing. These are things we’re currently working on," Hudson said.

MHRA is also working on "day one issues ... to make sure we can address [them] to ensure continuity of supply," Hudson said. The extent to which these issues disrupt the operations of drug companies will depend on what relationship the UK has with the EU on its day of departure. That is an uncertainty that is causing concern at companies.

"One of the big threats and questions that we currently face is going to be what happens as the EMA moves ... somewhere else and what disruption will that cause," Mene Pangalos, executive vice president of AstraZeneca's Innovative Medicines and Early Development Biotech Unit, said at the Lords committee meeting.

Pangalos wants "a seamless regulatory approval process" but negotiations are yet to reach the point the UK can guarantee that will happen. Hudson did guarantee that, "As of day one, we will be harmonized." However, having the same regulations as the rest of the EU will not prevent disruption if the UK is cut off from the agencies that implement those requirements.

Ombudsman Clears EMA of Wrongdoing in Review of HPV Vaccine Safety

The European Ombudsman has cleared EMA of wrongdoing in its review of the safety of human papillomavirus (HPV) vaccines. Complainants triggered the Ombudsman probe by raising concerns about the transparency, impartiality and handling of EMA’s 2015 review of the vaccines’ safety.

Three researchers, a doctor and a member of the European Parliament filed the complaint, which accused EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) of committing errors during the handling of the review, failing to be transparent and inadequately dealing with conflicts of interest. PRAC’s review found no link between HPV vaccines and two syndromes, complex regional pain syndrome and postural orthostatic tachycardia syndrome.

The Ombudsman has now ruled in favor of EMA. The probe found no procedural issues that could have negatively affected PRAC’s ruling. PRAC performed a complete, independent examination of the scientific evidence, the Ombudsman said, and fully complied with EMA’s conflict of interest policy.

"There was no maladministration by EMA in the handling of the referral procedure on HPV vaccines," the Ombudsman concluded.

However, while concluding EMA acted appropriately, the Ombudsman thinks it could do more to be seen to be acting appropriately. The idea that perceptions of bias or wrongdoing are significant even if the agency acted entirely appropriately came up earlier this year, when the Ombudsman opened an investigation into EMA’s pre-submission meetings with sponsors.

The Ombudsman wants PRAC to do more to dispel such perceptions, notably by making it easier for citizens to request access to documents and proactively sharing as much information as possible. EMA has agreed to review its confidentiality requirements to enable experts to discuss details of scientific debates after conclusions are reached.

"The agency welcomes two suggestions made by the Ombudsman to further improve the information on its scientific assessments that it provides to the public and will now explore ways to address these," EMA wrote in its response to the ruling.

EMA’s Committee for Medicinal Products for Human Use (CHMP) is to reexamine its decision to reject Santhera Pharmaceuticals’ application to expand the label of Raxone to cover patients with Duchenne muscular dystrophy (DMD).

CHMP knocked back the application last month after concluding the data presented by Santhera failed to show Raxone slows the worsening of breathing ability in patients with DMD, the claim targeted by the filing. Santhera responded by asking CHMP to reexamine its application.

The EMA committee accepted the request at its October meeting, starting a process that will see it take a second look at the filing. CHMP reexamines filings within 60 days of receiving the applicant’s document detailing its grounds for the request.

Some companies have succeeded in overturning CHMP decisions. Last year, CHMP granted conditional approval to Takeda’s multiple myeloma drug Ninlaro at the second time of asking. CHMP made that U-turn after talking to cancer experts about the merits of the filing.

Other News:

EMA is seeking feedback on the implementation of veterinary risk-assessment requirements. The requirements cover the control of elemental impurities and propose a phased-in implementation of a European Pharmacopoeia monograph that will come into force at the start of next year. EMA is accepting feedback on the draft until 16 November. Draft Document

EMA has reported a 13% decline in sales of antibiotics for animal use in Europe. The decline covers the period from 2011 to 2015. EMA presented the trend as evidence efforts to promote prudent use of antibiotics are starting to change veterinary practices. EMA Notice